Freyr assisted a US-based client in submitting its Information Request Submission (IRS) to the United States Food and Drug Administration (US FDA) for its product to treat colic conditions.
The company lacked experience handling IND-based maintenance activities. With adequate support from Freyr, the IND was reviewed, and expert advice was provided on the gaps, and submitted.
Check the proven case to learn how Freyr’s RA team assisted in preparing and submitting the IRS for a US-based company.
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